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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 060463


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NDA 060463 describes GARAMYCIN, which is a drug marketed by Schering and is included in seven NDAs. Additional details are available on the GARAMYCIN profile page.

The generic ingredient in GARAMYCIN is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 060463
Tradename:GARAMYCIN
Applicant:Schering
Ingredient:gentamicin sulfate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:OINTMENT;TOPICALStrengthEQ 0.1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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